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STUDY OF HALOPERIDOL AND PIMOZIDE IN TOURETTE SYNDROME

STUDY OF HALOPERIDOL AND PIMOZIDE IN TOURETTE SYNDROME
氟哌啶醇和匹莫齐特治疗抽动秽语综合征的研究
批准号:
3400896
负责人:
ARTHUR K SHAPIRO
金额:
$15.51万
依托单位国家:
美国
项目类别:
财政年份:
1984
资助国家:
美国
项目状态:
已结题
起止时间:
1984-04-01 至 1987-08-31

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中文摘要
翻译
氟哌啶醇被认为是治疗糖尿病的首选药物。 多发性抽动症(TS)虽然没有双盲研究 与安慰剂或其他神经镇静剂相比,有效性已经完成。 考虑到这一需要,我们建议进行随机、双盲、 两种药物的临床疗效和不良反应的平行研究 氟哌啶醇、吡莫齐特和安慰剂治疗90例TS患者。假设, 肯定地说,氟哌啶醇和匹莫齐特会改善体征吗? TS的症状明显多于安慰剂和匹莫齐特 与氟哌啶醇相比,氟哌啶醇会产生更多的改善和更少的改善 运动障碍的不良反应。次要目的是测量和评估 与TS治疗相关的认知功能障碍的性质 氟哌啶醇与匹莫齐特的关系及回顾性研究 药物剂量、改善、不良反应和选定的人口统计学之间的关系 以及与疾病相关的变量。这项研究将随机分配患者 三种治疗条件中的一种。两名临床医生将就 诊断和严重程度分级。多项改进措施和 不良反应将由治疗医生、患者和 两名独立法官根据他们对病人录像带的评分。 认知测试将被用来衡量对认知的影响 氟哌啶醇,吡莫齐特和安慰剂。 多发性抽动症是一种慢性疾病,常致残,起病于 童年。这些症状通常是奇怪的和具有社会局限性的 会限制心理社会、教育和职业功能。严重者 症状会导致缺乏自尊、社交退缩、变得 回家,还有住院治疗。慢性用药通常是 需要抑制抽搐症状和允许有效的运作。 医生有责任防止因 长期服药,特别是如果这些药物干扰学习的话 在已经患有严重残疾的患者中。目的 这项研究提供的数据将允许选择最少的 治疗TS和a的损害但最有效的药物 可能的最佳剂量范围,以防止有害的不良影响。
英文摘要
Haloperidol is considered to be the drug of choice for the treatment of Tourette Syndrome (TS) although no double-blind studies of its effectiveness compared to placebo or other neuroleptics have been done. With this need in mind, we propose to conduct a randomized, double-blind, parallel study comparing the clinical effectiveness and adverse effects of haloperidol, pimozide and placebo in 90 TS patients. The hypotheses, stated positively, are that haloperidol and pimozide will improve the signs and symptoms of TS significantly more than placebo and that pimozide compared to haloperidol will yield significantly more improvement and fewer akinesic adverse effects. Secondary purposes are to measure and assess the nature of the cognitive impairment associated with the treatment of TS with haloperidol and pimozide, and to retrospectively study the relationship between drug dosage, improvement, adverse effects, and selected demographic and illness-related variables. The study will randomly assign the patients to one of the three treatment conditions. Two clinicians will agree on diagnosis and rating of severity. Multiple measures of improvement and adverse effects will be rated by the treating physician, the patient and two independent judges based on their ratings of videotapes of patients. Tests of cognition will be administered to measure the effect on cognition of haloperidol, pimozide and placebo. Tourette syndrome is a chronic, often disabling illness with onset in childhood. The often bizarre and socially limiting nature of the symptoms can restrict psychosocial, educational and vocational functioning. Severe symptoms can result in low self-esteem, social withdrawal, becoming homebound, and hospitalization. Chronic drug administration is often required to suppress tic symptoms and permit effective functioning. Physicians have a responsibility to prevent disabling adverse effects due to chronic drug administration, especially if these interfere with learning in patients already afflicted with a severe disability. The purpose of this study is to provide data which will allow selection of the least impairing but most effective medication for the treatment of TS and a possible range of optimal dosage to prevent harmful adverse effects.
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STUDY OF HALOPERIDOL AND PIMOZIDE IN TOURETTE SYNDROME
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